Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine · 1 trial · 1 indication
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
| Arm | Type | Description |
|---|---|---|
| GSK 257049-Lot 1 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 2 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 3 Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Pilot Group | EXPERIMENTAL | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) | BIOLOGICAL | 4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination. * Sig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |